Chronic prostatitis or chronic pelvic pain syndrome is an extremely prevalent disease in men (Collins M M, et al., xe2x80x9cHow common is prostatitis? A national survey of physician visits,xe2x80x9d Journal of Urology, 159:1224-1228 (1998)). Although the epidemiologic evidence is limited, it appears that the prevalence of prostatitis is approximately 2-9% in adult men. It has been suggested that 35-50% of men are affected by prostatitis at some time in life. Approximately 2 million ambulatory patient visits are made annually for prostatitis, accounting for 8% of all visits to urologists and 1% of all visits to primary care physicians. Many men remain symptomatic for much of their lives.
Chronic prostatitis is characterized by evidence of prostatic inflammation and by the presence or absence of white blood cells in prostatic fluid and/or pain associated with the prostate. This syndrome does not exist prior to puberty but has a peak incidence between the ages of 18 and 50. Suggestions as to the origins of these conditions have included a chemical imbalance in the prostate, infection undetected by current microbiological methods and autoimmunity to the prostate gland itself.
Chronic non-bacterial prostatitis and prostatodynia (Chronic Pelvic Pain Syndrome) is characterized by pain and/or discomfort in the genitourinary, pelvic or perineal area and is associated with variable voiding and sexual dysfunction. Chronic nonbacterial prostatitis [Chronic Pelvic Pain Syndrome NIH Category IIIA] is an inflammatory and painful condition of unknown etiology characterized by excessive inflammatory cells in prostatic secretions despite a lack of documented urinary tract infections, and negative bacterial cultures of urine and prostatic secretions. Prostatodynia [Chronic Pelvic Pain Syndrome NIH Category IIIB] is a painful condition of unknown etiology characterized by a decided lack of inflammatory cells in prostatic secretions, no documented urinary tract infections and negative bacterial cultures in urine and prostatic secretions. Chronic nonbacterial prostatitis is more common than bacterial prostatitis. Symptoms mimic those of chronic bacterial prostatitis. Patients usually show an increase in the number of white blood cells and oval fat bodies in their expressed prostatic secretions. However, they rarely have a history of urinary tract infection, and lower-tract localization cultures fail to reveal a pathogenic organism.
Currently, there are no established treatments for chronic prostatitis. Antibiotics are often prescribed empirically, but with little evidence of efficacy. Alpha blockers are sometimes prescribed, but their efficacy has not been established. Hot sitz baths and anticholinergic drugs can generally be employed to provide some symptomatic relief.
Although the present invention is not limited to a specific mechanism of action, it is noted that COX-2 expression is increased in prostatic tissue involved in chronic prostatitis.
COX-2 selective inhibitors can be administered alone as well as in combination with other active agents. In accordance with the present invention, administration of a COX-2 selective inhibitor reduces both the inflammation and pain that are associated with chronic prostatitis.
The present invention relates to the use of a COX-2 selective inhibitor for the treatment or prevention of chronic prostatitis or chronic pelvic pain syndrome comprising the administration of a COX-2 selective inhibitor in an amount effective to treat or prevent chronic prostatitis.